The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed that the Dutch Food and Consumer Product Safety Authority on 30th May, 2017, recalled Heartmate II LVAS Pocket System Controller due to risk of patient injury and/or death during backup controller exchange.

The Heartmate II LVAS Pocket system controller is a power supply that connects to the implanted Heartmate II LVAS pump through a lead (driveline) under the skin. The controller helps power the LVAS system. The Heartmate II LVAS System is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.The pocket System controller is provided to each patient for use in case of a device alarm or malfunction. Change to backup system controller should be done quickly and in the hospital to avoid risk of serious injury or death.

The details of the product are as follows:

Heartmate II Left Venticular Assist (LVAS) Pocket System Controller

Model/Item Numbers: 105109, 106015, 106762, 107801

Manufacturing Dates: July 2012 to March 2017

Distribution Dates: July 2012 to March 2017

A total of 70 reports of incidents in which the controller has malfunctioned after an exchange including nineteen (19) injuries and twenty-six (26) deaths have so far been received by the manufacturer. All the deaths occurred when the patients attempted to exchange controllers while away from the hospital.

Healthcare provider’s action

Healthcare providers treating patients with left ventricular heart failure using the Heartmate II LVAS Pocket system Controller should be aware of this risk and also communicate the same to their patients with Heartmate II LVAS System Controller. This will help prevent health risks associated with the use of the device.

Healthcare providers and patients should report adverse events associated with the use of this system to the nearest NAFDAC office, NAFADC PRASCOR (20543 TOLL FREE from all networks) or via
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The National Agency for Food and Drug Administration and Control has been notified that the British Medicines and Healthcare Products Regulatory Agency (MHRA) have announced the global recall of various High Concentration Oxygen Masks manufactured by ConvaTec and Unomedical. High Concentration Oxygen Masks are intended to deliver high concentration oxygen to patient airways.

Reason for recall

Product reports confirmed that the devices are not meeting the desired expectation.

In some cases, the tubing was found to be disconnecting from the oxygen mask, prior to use or during use causing disruption in oxygen supply.

Healthcare providers in possession of these affected products should stop using them.

Healthcare providers and patients are encouraged to report adverse events associated with the use of these products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via
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The National Agency for Food and Drug Administration and Control has been notified by the U.S. Food and Drug Administration (U.S. FDA) of its approval of label changes regarding the use of general anesthetic and sedation medicines in children younger than 3 years.

These general anesthetic and sedation drugs are necessary for surgery or other painful and stressful procedures in patients including infants, children and pregnant women. They are administered intravenously or by inhalation to render a patient reversibly unconscious and unresponsive in order to allow surgeons operate on the patient.

The label changes include the following warnings;

Exposure to these medicines for lengthy periods of time or over multiple surgeries or procedures may negatively affect brain development in children younger than 3 years.

Exposure to the use of these medicines on pregnant and pediatric patients for more than 3 hours can cause widespread loss of nerve cells in the developing brain. Studies in young animals suggested these changes resulted in long-term negative effects on the animals’ behavior or learning.

Healthcare Provider Action

Continue to ensure patients counseling and discussion on the benefits and risks of surgeries or procedures that require general anesthesia and sedation drugs.

Parents, caregivers and pregnant women should be encouraged to ask questions on their concerns about these medicines.

Healthcare providers as well as patients are encouraged to report adverse events or side effects related to the of these medicines to NAFDAC PRASCOR (20543-Toll free from all networks) or via
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The attention of the Agency has been drawn to the FDA’s alert to physicians who care for pregnant women meeting CDC Zika virus clinical criteria and/or CDC Zika virus epidemiological criteria, that the U.S. commercial testing facility, Laboratory Corporation of America (LabCorp). It has been reported that some false positive results from the ZIKV Detect test. The FDA has not yet determined if the reported false positives are related to the ZIKV Detect test or the commercial testing facility. While the FDA has not yet determined if the reported false positives are related to the ZIKV Detect test or the commercial testing facility, it is important to remember that IgM tests remain useful in ruling out Zika exposure but require confirmatory testing.

The ZIKV Detect IgM Capture ELISA is used for the preliminary (presumptive) detection of Zika virus IgM antibodies in human sera collected from patients with a history of clinical signs and symptoms associated with Zika virus infection (Centers for Disease Control and Prevention [CDC] clinical criteria for Zika virus) and/or a history of residence in or travel to a geographic region with active Zika transmission at the time of travel (CDC Zika virus epidemiological criteria).

Healthcare providers’ action

Inform their patients that presumptive positive results need to be confirmed, so that pregnant women are not making health care decisions based on incomplete information.

Notify the laboratory of the patient’s pregnancy to facilitate prioritization of confirmatory testing by CDC or disqualified laboratories.

Report adverse events or side effects related to the use of the product to NAFDAC PRASCOR (20543, toll free from all network) or via individual case safety report forms or via email:
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and also encourage patients to do same.

The attention of the agency has been drawn to the recall of a batch of Hydrocortisone injection as a precaution following the receipt of a number of complaints that the solution in some ampoules has a yellowish appearance. Hydrocortisone injection is used to treat symptoms of low corticosteroid levels (lack of certain substances that are usually produced by the body and are needed for normal body functioning). It is also used to treat severe allergic reactions. Hydrocortisone injection is used in the management of multiple sclerosis (a disease in which the nerves do not function properly), lupus (a disease in which the body attacks many of its own organs), gastrointestinal disease, and certain types of arthritis. It is also used to treat certain conditions that affect the blood, skin, eyes, nervous system, thyroid, kidneys, and lungs. Hydrocortisone injection is in a class of medications called corticosteroids. It works to treat people with low levels of corticosteroids by replacing steroids that are normally produced naturally by the body. It also works to treat other conditions by reducing swelling and redness and by changing the way the immune system works.

The attention of the National Agency for Food and Drug Administration and Control (NAFDAC) has been drawn to the recall of three brands of Fleming pharmaceutical products on November 14, 2016 by the Hong Kong Department of Health (DH) over misinformation of the package label instruction which do not match with the registered version, thereby rendering the products unregistered and unsafe for human consumption. The products which contained amoxicillin and clavulanic acid were supplied by Hong Kong-based Medreich Pharmaceutical franchise, Medreich Far East Limited.

THE RECALLED PRODUCT DETAILS:

PRODUCT NAME

REGISTRATION NUMBER

Fleming Tablets 1g

HK- 52242

Fleming for oral suspension 457mg/5m

HK- 56072

Fleming for suspension 228.5mg/5ml

HK- 56069

HEALTHCARE PROVIDER’S ACTION

Healthcare providers and patients in possession of these affected products should stop using them.

Healthcare providers and patients are encouraged to report adverse events associated with the use of these products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via
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The attention of the National Agency for Food and Drug Administration and Control (NAFDAC) has been drawn to the recall of three lots of Fentanyl Citrate Injection, 50mcg/mL over confirmed ampoules with broken tips.

Fentanyl is a potent, synthetic opioid pain medication with a rapid onset and short duration of action. It is a potent agonist at the μ-opioid receptors. Fentanyl Citrate Injection is indicated as short-term analgesia during anaesthetic periods, premedication, induction and maintenance and as an analgesic supplement in general or regional anaesthesia. Fentanyl Citrate is used for intravenous (IV) or intramuscular (IM) use.

PRODUCT DETAILS:

NAME- Fentanyl Citrate Injection 50mcg/mL

# Affected Lot Numbers: 59277EV, 60028EV

EXPIRY DATES- 1st November 2017, 1st December 2017.

HEALTHCARE PROVIDER’S ACTION

Healthcare providers should provide adequate warnings to stop using the affected products.

Healthcare providers and patients are encouraged to report adverse events associated with the use of these products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via
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The National Agency for Food and Drug Administration and Control has been notified about the Essure labeling which now includes the addition of a boxed warning and a Patient Decision Checklist, both intended to support patient counseling and understanding of benefits and risks associated with Essure, as well as what to expect during and after the Essure procedure. The boxed warning includes safety statements to clearly communicate significant side effects or adverse outcomes associated with this device and information about the potential need for removal.

The Patient Decision Checklist provides key information about the device, its use, and safety and effectiveness outcomes, of which the patient should be aware and discuss with her doctor as she considers her sterilization options. Bayer also incorporates important modifications to the patient counseling and device removal sections of the labeling to provide physicians with additional guidance in these critical areas.

Adverse event associated with the use of this product should be reported to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via
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The attention of the agency has been drawn to the voluntary recall by Hong Kong Centre for food safety of Original Taco seasoning mix 24oz bottle produced by McCormick &Company Incorporated in USA over undeclared milk allergen content which could cause hives ,stomach upset ,vomiting and in anaphylaxis in rear cases.

People who have allergy or severe sensitivity to milk run the risk of life threatening allergic reaction if they consume this product.

Recalled Products Information

Product Name: Original Taco seasoning mix

Product Lot Codes: 932046, 9000272507

Product Name

Lot No

Expiration Date

Case Pack

UPC Number on shipper

Original Taco seasoning mix

930246

27th June 2018

12/case

52100302461

Original Taco seasoning mix

900272507

16th Sept 2018

12/case

5210012476

NAFDAC implores importers to ensure that they do not import the above products.

All outlets with these products should immediately stop sale and submit products to the nearest NAFDCAC office for appropriate action.

The attention of the Agency has been drawn to recent warning by the US Food and Drug Administration concerning some Medicines containing Pioglitazone (They include Actos, Actoplus Met, Actopus Met XR, Duetact, and Oseni) which increases the risk of bladder cancer in patients who have Type 2 diabetes as its often recommended for them.

Pioglitazone is a drug approved to improve blood sugar control, along with diet and exercise, in adults with type 2 diabetes. This Drug is in a class of medications called thiazolidinediones. It works by increasing the body's sensitivity to insulin, a natural substance that helps control blood sugar levels. It is not used to treat type 1 diabetes (condition in which the body does not produce insulin and, therefore, cannot control the amount of sugar in the blood) or diabetic ketoacidosis (a serious condition that may develop if high blood sugar is not treated).

POSSIBLE RISK ASSOCIATED WITH THIS DRUG:

Patients with type 2 diabetes may experience the following symptoms after using Pioglitazone which may be due to bladder cancer and they are as follows;

Health care professionals are advised not to use pioglitazone in patients with active bladder cancer, and should carefully consider the benefits and risks before using Pioglitazone in patients with a history of bladder cancer.

Patients are advised to contact their health care professionals if they experience any signs or symptoms after starting Pioglitazone, as these may be due to bladder cancer:

The Agency also encourages healthcare professionals and patients to report adverse events or side effects related to the use of these products to NAFDAC PRASCOR (20543-Toll free from all networks) or via
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The Agency warns against sale and Distribution of Nancy’s Fancy Butterscotch Budino Gelato and Nancy’s Fancy Peanut Butter with Crunchy Peanuts Gelato as they were produced in a co-packing facility and has the potential of being contaminated with Listeria monocytogenes, an organism which can cause fatal infection in young children, frail or elderly people and others with weakened immune system.

NAFDAC implores importers to ensure that they do not import these products and members of the public who have already purchased these products to noy eat them but to throw them away or take them back to point of purchase

The attention of the Agency has been drawn to the recent warning by the Singapore`s Health Science Authority against consumption of longred oyster and lifespark 100% Natural pain Relief Supplement over undeclared potent ingredients of all lots (i.e. ingredients not specified on the label). The product longred Oyster-x contains Sildenafil which is used to treat male erectile dysfunction and may lead to decreased or loss of vision and hearing, low blood pressure, strokes and heart attacks and LifeSparks 100% Natural pain supplement on the other hand contains chlorpheniramine, diclofenac, paracetamol, piroxicam, sulphamethoxazole and dexamethasone, a potent steroid usually prescribed for inflammatory

condition;

Risk Associated:

Long term unsupervised use of an oral steroid can cause increase blood glucose levels leading to diabetes, high blood pressure, cataracts,

Use of this product may pose a threat to consumers because the undeclared active (Sildenafil)ingredients may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrate

INFORMATION ON PRODUCTS

Manufacturer: Paul Harrison International Singapore.

Drug specification: 20 count bottles.

In view of this, the:

Patients taking these drugs should contact their health care professionals right away if they experience symptoms or any adverse effect related to the use of this product.

Healthcare professionals are implored to report adverse effect or side effects related to the use of these products to NAFDAC PRASCOR (20543-Toll free from all networks) or via
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The Agency has been informed that the Ivorian Ministry of Health and Public Hygiene on 18th October 2016, has commissioned a German Pharmaceutical company called, Merck Chemicals and Pharmaceutical laboratory for the detection of counterfeit drugs in the country. Merck Germany is a leading science and technology company, donated laboratory to the Ivory Coast (West Africa) thus indicating its support in fighting counterfeit medicines. The handing over of the laboratory took place during the opening of Merck’s new office in the capital of Abidjan.

The laboratory helps in the detection of counterfeit medicines with simple but reliable test methods for rapid drug quality verification. Almost 800 laboratory have been supplied to health facilities worldwide so far. Due to the donation of Merck, the laboratory is now also available in Côte d’Ivoire.

Patients and consumers are encouraged to report counterfeit drugs to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via
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